Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT00959868
Eligibility Criteria:
Inclusion Criteria:
1. Patient age must be \> 18
2. Histologic evidence of bladder cancer (superficial or muscle invasive) or
CIS as evidenced by:
* Patients presenting with superficial tumours and unknown pathological stage will have in-clinic bladder washings (performed cystoscopically) and biopsy (cup biopsy).
* Patients with recurrent superficial disease (Ta or T1) and tissue that is available for baseline studies (i.e. tissue from previous transurethral resection stored in paraffin blocks) will be eligible for trial without requiring cytology or biopsy.
* Patients with previously diagnosed T1 tumours and requiring re-resection of bladder tumour will be eligible if tissue from the original TURBT is available for baseline studies.
* Patients presenting as muscle invasive (\>T2) disease will be eligible if they are candidates for radical cystectomy and if baseline tissue from initial resections is available for baseline studies
3. No intravesical therapies within the previous 6 months
4. No evidence of metastatic disease as determined by physical exam, CT scan or chest- x-ray, where indicated.
5. ECOG status must be 0, 1, or 2
6. Laboratory requirements (within 7 days of treatment):
* negative urine cultures
* Absolute neutrophils count\> 1.5 x 109 cells/L, and platelets count\> 100 x 109/L,
* Total bilirubin \< 1.5 x upper normal limit (ULN), AST and/or ALT \< 1.5 x ULN, alkaline phosphatase \< 1.5 x ULN, and serum creatinine \< 1.5 x ULN.
* PTT and INR, within normal limits
7. Patient must be able to complete the quality of life questionnaires in either English or French
8. Patients must provide written informed consent.
Exclusion Criteria:
1. Patients with "indeterminate" or "negative" results from biopsy or cytology will be ineligible for the trial.
2. Patients taking warfarin or Coumadin anticoagulation therapy or who have a bleeding disorder. NOTE: Patients who require anticoagulation therapy while on study will be removed from study treatment.
3. Pregnant or lactating women
4. Patients not accessible for follow-up
5. Patients with an active urinary tract infection, upper tract urothelial tumors, active infection including tuberculosis, concurrent febrile illness or impaired immune response from any cause
6. Patients with contraindication to spinal or general anesthesia required for a transurethral resection or radical cystectomy
7. Recent (\<14 days) urethral trauma or inability to perform catheterization or cystoscopy safely
8. Patients known to have a serious illness or medical condition that would impair protocol treatment delivery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00959868
Study Brief:
Protocol Section:
NCT00959868